Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Public ClinicalTrials.gov record NCT02256631. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
Study identification
- NCT ID
- NCT02256631
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 83 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Days to 5 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2015 (Actual)
- Primary completion
- Jun 17, 2020 (Actual)
- Completion
- Dec 16, 2021 (Actual)
- Last update posted
- Feb 8, 2023
2015 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| David Geffen School of Medicine at UCLA NICHD CRS | Los Angeles | California | 90095-1752 | — |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 80045 | — |
| South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | 33316 | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| Pediatric Perinatal HIV Clinical Trials Unit CRS | Miami | Florida | 33136 | — |
| Emory University School of Medicine NICHD CRS | Atlanta | Georgia | 30322 | — |
| Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | 21287 | — |
| Bronx-Lebanon Hospital Center NICHD CRS | The Bronx | New York | 10457 | — |
| Jacobi Med. Ctr. Bronx NICHD CRS | The Bronx | New York | 10461 | — |
| Texas Children's Hospital CRS | Houston | Texas | 77030-2399 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02256631, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2023 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02256631 live on ClinicalTrials.gov.